Regulatory Affairs Specialist Aprilia

Regulatory Affairs Specialist
Aprilia
Lazio, Aprilia

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4, 500 employees and turnover of over Euro 2bn.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life. Job PurposeThe position to be covered is in the RA department of Recordati Campoverde site, reporting to the RA Manager. Responsible for regulatory affairs activities to assist in the submission of regulations, annual reports, registrations and lists. Ensure compliance with applicable regulations by jurisdiction, guidelines and standards. Assist in the creation and maintenance of regulatory files.

Key ResponsibilitiesWriting and updating EU-CTD (module 3. 2. S), US-DMF type II, J-DMF. Writing and updating documentation to be submitted to EDQM (CEP). Customer technical support. Worldwide submission of regulatory documentation. Submission in electronic format in EU, US and ROW countries. Required EducationDegree in Chemistry or Pharmaceutical Chemistry.

Required Skills and ExperienceBasic knowledge of EU and US regulatory procedures. Basic knowledge of API analytical techniques. GMP Basic knowledge. Good communication skills. Curiosity, precision and organization. Proven ability to work on own initiative or in a cross-functional team. Required LanguagesAt Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential. We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief. If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.

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